An Open Controlled Study of the Efficacy and Safety of Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Dynamics of the total score and improvement in the quality of life on the scale IPSS.
研究概览
简要总结
The primary purposes of the study are to evaluate the effectiveness of Ingaron in the complex therapy of chronic prostatitis, to assess the safety of using Ingaron in patients with chronic prostatitis.
详细描述
Literature data and the results of preclinical studies of interferon-gamma, as well as the features of the immunopathogenesis of chronic prostatitis, show the expediency of studying the use of Ingaron in this pathology.
The study was conducted to compare the efficacy and safety of Ingaron in combination with standard therapy with its subcutaneous administration and standard therapy in patients with chronic prostatitis.
The study was planned to include 50 male patients aged at least 18 years with a confirmed diagnosis of chronic prostatitis.
In the course of the study, Ingaron was administered at a dose of 500,000 IU once a day, every other day. In addition to Ingaron, patients received antibiotic therapy, anti-inflammatory drugs, alpha-blockers (if necessary). Magnetic laser therapy and prostate massage were also provided.
The patients were divided into 2 groups: main and control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years old (at the time of inclusion).
- •Objectively confirmed diagnosis of chronic prostatitis at the time of inclusion in the study (more than 10 leukocytes / field of view in cytological examination of prostate secretion; more than 1x10^5 CFU in bacteriological examination of prostate secretion (regardless of the nature of the inoculated microflora)).
- •Concomitant myco-, ureaplasma, gardnerella, chlamydial, urogenital viral infection is not excluded.
- •The volume of residual urine (Q max) is not more than 70 ml.
- •The maximum urination rate, according to urofluometry, is not less than 10 ml / sec.
- •Allowed previous therapy of chronic prostatitis, not less than 30 days after the end of the last course of treatment.
- •If there is a history of surgical treatment for benign prostatic hyperplasia, the time from the moment of surgery to inclusion in the study is at least 6 months.
- •Availability of written informed consent to participate in the clinical study.
排除标准
- •Positive test results for syphilis (Wasserman reaction), hepatitis (HbsAg, anti-HCV), HIV infection.
- •Known allergic reactions to interferons, or other significant allergic diseases.
- •A history of autoimmune disease.
- •The presence of external drains of the organs of the genitourinary system.
- •The presence of histologically proven prostate cancer.
- •A history of diabetes mellitus.
- •Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
- •Condition after organ transplantation, constant intake of immunosuppressive drugs.
- •Severe pathology from the cardiovascular system (uncontrolled arterial hypertension, unstable angina pectoris, congestive heart failure, cardiac arrhythmias), a history of myocardial infarction or cerebrovascular accident within the last 6 months.
- •Severe pathology of the liver (increased content of AST, ALT 2 times higher than the upper limit of the norm, the content of total bilirubin> 2 mg / dl), kidney (creatinine content> 1.5 mg / dl); signs of hepatic and / or renal failure.
- •Other serious (acute or chronic) pathological conditions, including mental illness, as well as abnormalities in laboratory parameters, which, in the opinion of the investigator, may increase the risk associated with participation in the study or affect the interpretation of the efficacy and safety data obtained in this research.
- •Alcohol and / or drug dependence.
- •Participation in other clinical trials in the last 3 months prior to inclusion.
研究组 & 干预措施
Experimental
Patients received Ingaron 500,000 IU subcutaneously once a day, every other day. The course of treatment is 7 injections. The first injection was given on the first day of active therapy. Subsequent injections were given every other day. The period of active therapy was 14 days.
干预措施: Interferon gamma human recombinant (IFN-G) (Drug)
结局指标
主要结局
Dynamics of the total score and improvement in the quality of life on the scale IPSS.
时间窗: Day 13
The sum of points was assessed, as well as the symptom complex on the basis of the "IPSS" questionnaire - the international system for the total assessment of symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms was assessed from 0 to 6 points. symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms is rated from 0 to 6 points.
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
时间窗: Day 90
The effect of interferon-gamma on T-lymphocytes.
Evaluation of cytological parameters of prostate secretion.
时间窗: Day 90
The number of epithelial cells.
Evaluation of indicators of urination. Urofluometry.
时间窗: Day 90
Urofluometry.
Evaluation of indicators of urination. General urine analysis.
时间窗: Day 90
General urine analysis.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
时间窗: Day 90
The content of lymphocytes in prostate secretion.
Evaluation of indicators of urination. Ultrasound of the prostate gland.
时间窗: Day 90
Ultrasound of the prostate gland.
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
时间窗: Month 6
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
时间窗: Month 6
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
次要结局
未报告次要终点